DIY-style kit makes drugs on demand for crisis situations

This portable pharmaceutical manufacturing system is making access to life-saving medicine easier – all while cutting costs and wait times.

MIT researchers have developed a compact, portable pharmaceutical manufacturing system that can be reconfigured to produce a variety of drugs on demand.

Just as an emergency generator supplies electricity to handle a power outage, the new system could be rapidly deployed to produce drugs needed to handle unexpected disease outbreaks or prevent shortages caused by a manufacturing plant shutdown.

“Think of this as the emergency backup for pharmaceutical manufacturing,” said Allan Myerson from the MIT Department of Chemical Engineering.

“The purpose is not to replace traditional manufacturing; it’s to provide an alternative for these special situations.”

His colleague Professor Klavs Jensen said it could also be used for small quantities of drugs needed for clinical trials, or to treat rare diseases.

“The goal of this project was to build a small-scale, portable unit that was completely integrated. You could imagine being able to ship it anywhere and as long as you had the right chemicals you could make pharmaceuticals,” Jensen said.

Traditional pharmaceutical manufacturing, also known as ‘batch processing’, can take weeks or months. Active pharmaceutical ingredients are synthesised in chemical manufacturing plants and then shipped to other sites to be converted into a form that can be given to patients, such as tablets, drug solutions or suspensions.

This system offers little flexibility to respond to surges in demand and is susceptible to severe disruption if one of the plants has to shut down.

Many pharmaceutical companies are now looking into developing an alternative approach known as flow processing — a continuous process that is done all in one location.

In the new endeavour, funded by the Defense Advanced Research Projects Agency (DARPA), the MIT researchers built on what they learned from the Novartis-funded project to create a much smaller, transportable device.

Their new system can produce four drugs formulated as solutions or suspensions — Benadryl, lidocaine, Valium and Prozac. Using this apparatus the researchers can manufacture about 1000 doses of a given drug in 24 hours.

Key to the continuous system is the development of chemical reactions that can take place as the reactants flow through relatively small tubes, as opposed to the huge vats in which most pharmaceutical reactions now take place. Traditional batch processing is limited by the difficulty of cooling these vats, but the flow system allows reactions that produce a great deal of heat to be run safely.

The chemical reactions required to synthesise each drug take place in the first of two modules. The reactions were designed so that they can take place at temperatures up to 250°C and pressures up to 17 atm.

By swapping in different module components, the researchers can easily reconfigure the system to produce different drugs within the span of a few hours.

In the second module, the crude drug solution is purified by crystallisation, filtered and dried to remove solvent, then dissolved or suspended in water as the final dosage form. The researchers also incorporated an ultrasound monitoring system that ensures the formulated drug solution is at the correct concentration.

John Lewin, the division director of critical care and surgery pharmacy at Johns Hopkins Hospital, says this type of pharmaceutical manufacturing could bring down production costs and help patients get better access to the drugs they need.

“This sets the foundation for a new paradigm in terms of the way we manufacture pharmaceuticals and distribute them to patients,” he said.

An advantage of this small-scale system is that it could be used to make small amounts of drugs that would be prohibitively expensive to make in a large-scale plant. This would be useful for so-called ‘orphan drugs’ ­– drugs needed by a small number of patients.

“Sometimes it’s very difficult to get those drugs because economically it makes no sense to have a huge production operation for those,” Jensen said.

It could also be useful in regions with few pharmaceutical storage facilities, as drugs can be produced on demand, eliminating the need for long-term storage.

The researchers are now working on the second phase of the project, which includes making the system about 40 per cent smaller and producing drugs whose chemical syntheses are more complex.

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